ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100— 510(k) K041881
Substantially EquivalentHypoguard USA, Inc.
FDA 510(k) clearance K041881 for ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100, Substantially Equivalent on 2005-03-25. Applicant: Hypoguard USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Hypoguard USA, Inc.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code CGA
view allMore clearances from Hypoguard USA, Inc.
view all- K053079 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
- K051514 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
- K033851 — DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
- K031388 — MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K024347 — EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.